A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease (Enith-MACE)
2 novembre 2026 mis à jour par: Hoffmann-La Roche
A Phase III, Randomized, Double-Blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of Enicepatide in Participants With Overweight or Obesity and Cardiovascular Disease
The purpose of this study is to evaluate the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), as a therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults living with overweight or obesity and established cardiovascular disease (CVD), with or without type 2 diabetes mellitus (T2DM).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
8200
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Sauvegarde des contacts de l'étude
- Nom: Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below
- Numéro de téléphone: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Body Mass Index (BMI) ≥25.0 kilograms per meter square (kg/m2)
- Have established and stable cardiovascular disease (CVD)
- Participants should be treated with stable (per investigator judgment) background therapy for CVD, such as hyperlipidemia and T2DM (if relevant), as per local and international guidelines, excluding use of GLP-1 RA-based therapies
- For participants with T2DM: HbA1c ≤10% based on central laboratory assessment at Screening
Exclusion Criteria:
- History of type 1 diabetes mellitus, or any lifetime history of ketoacidosis or hyperosmolar state/coma within 12 months prior to Screening
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study per investigator judgment
- Any preplanned major medical procedure or surgery at the time of Screening including planning to have a surgical, endoscopic, or device treatment for obesity
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- Chronic dialysis (e.g., chronic hemodialysis, chronic peritoneal dialysis)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Arm 1: Placebo
Participants will receive volume-matched placebo. |
Participants will receive volume-matched placebo as per the schedule described in the protocol. |
|
Expérimental: Arm 2: Enicepatide
Participants will receive enicepatide. |
Participants will receive enicepatide as per the schedule described in the protocol.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to First Occurrence of Any Component of 5-point (5P) MACE
Délai: From randomization up to 4.2 years
|
The components of this composite 5P MACE endpoint consist of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for heart failure (HHF) or urgent heart failure (HF) visit, or urgent coronary revascularization. |
From randomization up to 4.2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to First Occurrence of Any Component of 3-point (3P) MACE
Délai: From randomization up to 4.2 years
|
The components of this composite 3P MACE endpoint consist of CV death, non-fatal MI or non-fatal stroke. |
From randomization up to 4.2 years
|
|
Time to New-Onset T2DM
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
|
Total Occurrence of All-Cause Hospitalization
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Time to Death From Any Cause
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to CV Death
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Incidence and Severity of Adverse Events
Délai: From baseline up to 4.2 years
|
From baseline up to 4.2 years
|
|
|
Time to First Occurrence of Any Component of 4-point (4P) MACE
Délai: From randomization up to 4.2 years
|
The components of this composite 4P MACE endpoint consist of CV death, non-fatal MI, non-fatal stroke, or HHF or urgent HF visit. |
From randomization up to 4.2 years
|
|
Time to First Occurrence of HHF, Urgent HF Visit, or CV Death
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
|
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Short Form 36 Health Survey Version 2.0 (SF-36 V2) Acute Form Physical Functioning Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Physical Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Bodily Pain Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form General Health Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Vitality Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Social Functioning Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Emotional Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Health Domain Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Physical Component Summary Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Component Summary Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in Health Status as Assessed by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) Score
Délai: From baseline through Week 48
|
From baseline through Week 48
|
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Time To First Occurrence of Sustained ≥40% Estimated Glomerular Filtration Rate (eGFR) Decline From Baseline, End Stage Kidney Disease (ESKD), or Renal Death
Délai: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Change From Baseline in Body Weight
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Waist Circumference
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Waist-to-Height Ratio
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Systolic Blood Pressure
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Diastolic Blood Pressure
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Heart Rate
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Double Product
Délai: From baseline through the end of study (up to 4.2 years)
|
Double product is defined as heart rate multiplied by systolic blood pressure. |
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Pulse Pressure
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Mean Arterial Pressure
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Total Cholesterol
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Non-High-Density Lipoprotein (HDL)
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Low-Density Lipoprotein (LDL)
Délai: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in HDL
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Triglycerides (TG)
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Very-low-Density Lipoprotein (vLDL)
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Hemoglobin A1c (HbA1c)
Délai: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Délai: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in N-Terminal pro-B-Type Natriuretic Peptide (NT-proBNP)
Délai: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Clinical Trials, Hoffmann-La Roche
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
6 janvier 2027
Achèvement primaire (Estimé)
20 mars 2031
Achèvement de l'étude (Estimé)
17 avril 2031
Dates d'inscription aux études
Première soumission
2 novembre 2026
Première soumission répondant aux critères de contrôle qualité
2 novembre 2026
Première publication (Réel)
5 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 novembre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- WC46385
- 2026-526958-14-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .